Operations Engineering Manager
While this is intended to be an accurate reflection of the current job, it is not necessarily an exhaustive list of all responsibilities, skills, duties, requirements, or working conditions associated with the job. RTI Surgical, Inc., reserves the right to revise the job or require that other or different tasks are performed when circumstances warrant (i.e., emergencies, changes in personnel or staffing, workload, or technical developments).
SUMMARY:
RTI Surgical is global, industry-leading private label OEM with expertise in allograft, xenograft and synthetic-based implants. RTI began operations in 1998 when it spun off from the University of Florida Tissue Bank in 1998 with the goal of expanding the gift of tissue donation by pioneering tissue-based innovations that promote natural healing. Today, through integrated partnerships with customers, RTI develops and delivers restorative solutions to physicians and their patients.
As a Private Label Original Equipment Manufacturer (PLOEM) partner, RTI provides comprehensive turn-key services for development and product life cycle management in support of patients and leading medical technology companies. RTI’s implants are used in multiple surgical applications including dental, spine, sports medicine, plastic and reconstructive surgery, urology/urogynecology and trauma.
RTI is rooted in a steadfast commitment to quality, integrity, and patient safety with a focus on four key values:
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We are accountable to each other by trusting each other’s judgement and hold each other responsible for results.
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We find joy by striving to create a working environment that people enjoy.
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We fully engage by focusing our hearts and minds on our customers, patients, and each other.
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We adapt to change by working collaboratively to be flexible to the changing needs of our business.
RTI’s headquarters is located near Gainesville, Fla. in North Central Florida’s growing life sciences region, and has additional state-of-the-art facilities in the Greenville, N.C. and Germany.
Montagu Private Equity (“Montagu”), a leading European private equity firm, acquired RTI in 2020 and have supported the transformation of the company to its next level of potential.
RESPONSIBILITIES:
- Collaborates with Planning and Quality staff to ensure realization of an effective organization and promote strategic objectives to achieve and maintain World Class standards
- Protects RTI’s ability to realize revenue through effective utilization of resources
- Manages by influence to achieve goals in collaboration with critical company functions
- Ensures the quality and integrity of current process areas
- Works with site operations leadership and new product development to assist in ensuring operations readiness for the orderly and efficient implementation of new processes into production
- Provides clear, consistent, and measurable direction regarding timelines and deliverables
- Manage engineering activities required for the development, verification, and validation (process & development) of market-released product
- Coordinate the submission of engineering development requests and prioritizes according to company goals
- Direct and manage the daily activities and workflow of engineers
- Establish industry-accepted validated steam sterilization parameters
- Established validated gamma sterilization for various product types
- Develop engineering process controls to achieve consistent and predictable outcomes
- Train new employees on engineering quality assurance practices
- Champion proactive engineering activities throughout operations and with suppliers
- Participate in non-project-related activities to achieve corporate goals
CORE COMPETENCIES:
- Participates in the development and implementation of test plans, validations, SOPs, work instructions and other technical documentation as necessary.
- Understanding of equipment to ensure that it is properly designed, selected, installed and maintained based on a life-cycle philosophy of an asset
- Develops standards and plans for major engineering and packaging projects
EDUCATION/EXPERIENCE REQUIRED:
- Bachelor’s Degree in Engineering Required
- Minimum 3 years of direct supervisory experience
Physical Requirements:
Light work: Physically handle objects up to 20 lbs. occasionally.
Work Environment:
Office Setting - Open layout with assigned workstation or office
